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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2020, Vol. 25 ›› Issue (4): 460-466.doi: 10.12092/j.issn.1009-2501.2020.04.017

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Effects of pharmaceutical excipients on CYP3A activity and its guiding effects on quality and efficacy consistency evaluation of generic drugs

CHEN Siyu1,2, CHEN Lulu1,2, WANG Xintong1,2, LI Xiaohui1,2, YU Peng1,2, OUYANG Dongsheng1,2,3   

  1. 1Changsha DUXACT Co., Ltd., Changsha 410000, Hunan, China; 2Hunan Key Laboratory for Bioanalysis of Complex Matrix Samples, Changsha, 410000, Hunan, China;3Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha 410000, Hunan, China
  • Received:2020-01-06 Revised:2020-03-26 Online:2020-04-26 Published:2020-05-12

Abstract: The prescription and technology of pharmaceutical preparations are the basis for ensuring the quality and efficacy of medicines. Pharmaceutical excipients are important part of pharmaceutical preparations. As it's known to all that some pharmaceutical excipients can affect the activity of CYP3A, and then may influence the metabolism and bioavailability of its substrates in vivo. Relative bioavailability is a key element of generic drug research in China and the United States. Our country is advancing the quality and efficacy consistency evaluation of generic drugs. Therefore, it is of great practical significance to understand the impact of pharmaceutical excipients on CYP3A and its guiding role in consistency evaluation.

Key words: pharmaceutical excipients, CYP3A, consistency evaluation

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